2. UK market access for medical devices – CE, UKCA and UKNI marks

Last Updated on 06/11/2025 by Sarah Sarsby

CE Marking

Post-Brexit, the UK has allowed CE-marked medical devices to remain on the UK market. In GB, this is for a transitional period (see below and Section 4), and under the Windsor Framework Agreement , CE marking will be required for medical devices being sold in NI. Under European requirements (EU MDR 2017/745), medical devices are required to demonstrate compliance by display of a CE mark to be sold legally in the EU (and for as long as the CE mark continues to be accepted in the UK). See MHRA: Medical devices: EU regulations for MDR and IVDR (Northern Ireland) for CE requirements to place products on the NI market, including importer and registration obligations.

Qualifying NI goods may continue to be placed on the market in GB on the basis of a valid CE marking on an indefinite basis. This arrangement is as a result of the government’s commitments to Northern Ireland’s unfettered access to the market in the rest of the UK, and is underpinned by the UK Internal Market Act 2020.

On 21 May 2024, MHRA published a statement of policy intent for international recognition of medical devices, which provides for new, future routes to placing a medical device on the GB market via a certificate of International Reliance (IR). This draft policy indicates that a framework will be established to allow for reliance on assessments performed by comparable regulator countries (CRCs), resulting in a certificate of international recognition, which will allow the medical device to be placed legally on the GB market. The table below indicates the CRCs which are to be included in the envisioned IR framework.

MHRA intend to proceed with implementing the proposed international reliance routes. The proposed framework would provide an IR certificate that will grant devices access to the GB market, but it will not provide a UK Conformity Assessed (UKCA) marking, or UKCA certification. If, for the purposes of placing a device on the GB market, an IR certificate was issued based on an EU CE certification, the device could also be placed on the NI market. Given the feedback to the consultation, there will be further consultation on the indefinite acceptance of CE marking. The finalised IR framework and accompanying operational guidance are expected in 2026. IR routes will not open until the new UK medical device regime comes into force, also in 2026. In the meantime, for more detail, please see the MHRA Consultation on Medical Devices Regulations: Routes to market and in vitro diagnostic devices, and the Government response to international reliance, UKCA marking and in vitro diagnostic devices consultation proposals.

UKCA Marking

Where a medical device is placed on the GB market, by demonstrating compliance with the UK MDR 2002 (as amended), a UKCA mark should be displayed. UKCA marking is not currently mandatory for medical devices placed on the GB market, but will become so on expiry of the transitional periods, introduced by MHRA’s Spring 2023 Statutory Instrument (SI) (see Section 4 for full detail). Under the new UK regulatory regime, planned to be introduced in 2026, regulatory requirements in GB will be similar to those introduced by EU MDR/EU IVDR. Medical devices in GB, after a transition period, will be required to demonstrate compliance against these updated regulations either by undergoing a UKCA assessment procedure or through the international reliance procedure.

As outlined in the MHRA Consultation on Medical Devices Regulations: Routes to market and in vitro diagnostic devices, devices that have undergone the UK conformity assessment process may no longer be required to carry a UKCA mark or associated labelling to be placed on the GB market once the 2026 regulation update comes into force.

UKNI Marking

Under the terms of the Windsor Framework Agreement, from 1 January 2021 the rules for placing medical devices on the NI market will differ from those applicable to GB. As a result, the EU MDR and EU IVDR applied in NI from 26 May 2021 and 26 May 2022, respectively, in line with the EU’s implementation timeline. To apply a CE mark, high-risk medical devices and IVDs require review from an EU Notified Body. However, where a UK assessment body has provided an assessment in line with EU MDR or EU IVDR, a UK Northern Ireland (UKNI) mark can be applied for the purpose of placing the device on the NI market. MHRA guidance states:

“UK Notified Bodies can apply to be designated under the relevant EU legislation for the purposes of conducting conformity assessments for the Northern Ireland market. Please note that there are currently no UK Notified Bodies designated to undertake such assessments under the EU MDR or the EU IVDR. This section outlines the criteria for affixing a UKNI marking to devices should any UK Notified Bodies be designated in future. In addition to the CE marking, device manufacturers will also need to apply the UKNI indication if they choose to use a UK Notified Body (should any be designated in future) for mandatory third-party conformity assessment. Device manufacturers must never apply the UKNI indication on its own – it must always accompany a CE marking.”

Transitional arrangements (see Section 4) mean the CE mark will continue to be accepted to place medical devices on the UK market for the immediate future (until as late as June 2030 in some cases).

Medical devices fall into the following five groups across three classes:

• Class I – low risk, e.g. mouth ulcer film, headlice treatment, eyeglass frames, wheelchairs, stethoscopes.
• Class I Special Function (Is, Im, or Ir) – low risk devices that are sterile, perform measurement, or reusable surgical instruments.
• Class IIa – medium risk, e.g. dental fillings, cooling gels, paraffin dressings, short-term contact lenses, hearing aids.
• Class IIb – medium-to-high risk, e.g. condoms, insulin pens, eye drops, lung ventilators.
• Class III – high risk, e.g. medicated condoms, transdermal medication patch, pacemakers, breast implants, cerebral stimulators.

IVDs vary hugely from medical devices (despite being a sub-category of medical device) and therefore, these products have a different classification structure.

Under the UK MDR 2002 (as amended), IVDs fall into the following four groups across three classes:

• General IVD (low risk, e.g. tests for hormones, cardiac markers, clinical chemistry tests)
• Self-test IVD (medium risk, e.g. pregnancy test, cholesterol home tests)
• Devices included in Annex II List B (medium-to-high risk, e.g. detection of rubella, self-test for blood glucose)
• Devices included in Annex II List A (high risk, e.g. detection of HIV, detection of hepatitis, ABO blood grouping)

Class I devices and general IVDs are “self-certified”; a manufacturer is responsible for assembling and maintaining technical files and other compliance documents in line with the regulations and then makes a Declaration of Conformity (DoC) per product. The DoC is lodged with the relevant national regulatory authority (MHRA in the UK), which may ask to examine technical files. A DoC lasts for as long a product remains “substantially unchanged” in design, purpose, or application. As of 2022/23, the costs for placing a class I device or general IVD on the UK market (exclusive of companies’ own regulatory/compliance staff overheads) can be estimated as follows:

• £1000s – Product Development: These vary highly company-to-company and product-to-product; they are sunk costs, irrecoverable until/unless a product reaches the market and achieves success (up-front/one-off)
• £261 – MHRA Registration Fee: Payable for each registration application, a regulatory requirement before a product may be placed on the market (up-front/one-off, although similar fees apply for changes to registrations)
• £1000s – Technical File & Compliance Audits: Costs for periodic independent audits of companies’ own documents, in line with compliance best-practice, typically charged at between £200-£500 per hour/per product (regular/ongoing)
• £987 – Regulatory Advice Meeting Fee: This service is intended for complex queries that cannot be readily answered through existing online guidance. It aims to support manufacturers in interpreting regulatory requirements for their products.

Class I special function (measuring, sterile or reusable), all class II and above devices, self-test IVDs, IVDs included in Annex II list B, and IVDs included in Annex II list A are “3^rd party assessed”; a manufacturer must obtain and maintain a CE or UKCA certificate through an EU Notified Body (NB) designated by an EU Member State or UK Approved Body (AB) designated by MHRA. EU NBs and UK ABs are independent companies appointed under law by a relevant national authority which provide 3^rd party technical and compliance assessment. Provided a product remains “substantially unchanged” in design, purpose, or application, a certificate lasts for a set period of time (e.g. 3-5 years), after which 3^rd party re-certification must take place to verify continued conformity.

As of 2025/26, the costs for placing a class I special function, class II-and-above device, self-test IVD, IVD included in Annex II list B, or IVD included in Annex II list A on the UK market (exclusive of companies’ own regulatory or compliance staff overheads) might be estimated as follows:

• £1000s-to-£10000s – Product Development: These vary highly from company-to-company and product-to-product; they are sunk costs, irrecoverable until/unless a product reaches the market and achieves success (up-front/one-off).
• £261 – MHRA Registration Fee: Payable for each registration application, a regulatory requirement before a product may be placed on the market (up-front/one-off, although similar fees apply for changes to registration details).
• £1000s-to-£10000s – 3^rd Party Certification (Initial): Costs for 3^rd-party technical and compliance assessment to obtain an EC or UKCA Certificate, typically charged at between £200-£500 per hour/per product (up-front/one-off).
• £1000s – 3^rd Party Re-Certification (Ongoing): Costs for 3^rd-party technical and compliance assessment to renew an EC or UKCA Certificate, typically charged at between £200-£500 per hour/per product (regular/ongoing).
• £987 – Regulatory Advice Meeting Fee: This service is intended for complex queries that cannot be readily answered through existing online guidance. It aims to support manufacturers in interpreting regulatory requirements for their products.

On 02 September 25, MHRA published an update to the Government Response to the MHRA Consultation on Statutory Fees for medical devices.

The response outlines the final proposals for the introduction of a new annual fee to support post-market surveillance (PMS) activities for medical devices.  This follows extensive consultation with stakeholders across the sector the including responding to the challenges raised to the initial government fee proposals. The revised approach reflects feedback from industry, including trade associations, and trusted advisor groups, and aims to ensure a fairer distribution of costs while safeguarding patient safety and supporting innovation.

The new fee structure will come into effect from 1 April 26, with further guidance and support to be published in the coming months to help the medical devices community to prepare.  Important updates are:

• The new PMS fee will be based on GMDN level 2 categories (or Level 1 Category where no Level 2 exists), rather than the more granular Level 5, to ensure a fairer distribution of costs across the sector.

• The new fee will replace the current one-off registration fee of £261 and will be effective from 01-Apr-26 for all devices registered.

• The estimated fee is £300 from 1 April 2026, per GMDN level 2 category (or Level 1 Category where no Level 2 exists), with approximately 60% of manufacturers expected to pay only a single charge

• All fees will continue to be paid though the Device Online Registrations System (DORS), payable by either Worldpay or BACS/CHAPS.